Roles and Responsibilities:
- Quality Representation: Represent quality assurance on development teams, quality systems, and product improvement projects.
- Coaching & Guidance: Coach teams on ISO 9001, ISO 13485, cGMP, IEC 62304, and quality system processes throughout the product lifecycle.
- Cross-Functional Collaboration: Partner with development, manufacturing, and service teams to ensure product and service conformance, with focus on design controls, document controls, risk management (ISO 14971), and production/service controls.
- Documentation Assurance: Ensure compliant documentation, including Design History Files, Product, Process, and Service documentation, supporting product realization and commercialization.
- Regulatory Awareness: Stay current on industry standards and regulations, influencing interpretation of internal policies to ensure quality and compliance.
